UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	New assessment of therapeutic response to sorafenib for advanced hepatocellular carcinoma
Title of the study (Brief title)	New assessment of therapeutic response to sorafenib for advanced hepatocellular carcinoma
Region	Japan

Condition
Condition	hepatocellular carcinoma
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Although sorafenib has been shown to have significant survival advantages in patients with HCC, RECIST 1.1 may underestimate the efficacy because of modest tumor shrinkage. The aim of this study was to establish an objective radiological evaluation method for anti-tumor response of sorafenib with regard to survival, using LMS, an automated software to measure lesion size, volume and Hounsfield unit (HU) density.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Overall survival
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Child-Pugh class A 2) Barcelona Clinic Liver Cancer stage C 3) ECOG performance status 0 or 1
Key exclusion criteria	No follow-up CT images are available
Target sample size	40

Research contact person
Name of lead principal investigator	Yasunori Kawaguchi
Organization	Saga-Ken Medical Centre Koseikan
Division name	Department of Hepatobiliary and Pancreatology
Address	400 Nakabaru. Kase-machi, Saga-shi, Saga 840-8571, Japan
TEL	0952-24-2171
Email	kawaguy222@gmail.com

Public contact
Name of contact person	Yasunori Kawaguchi
Organization	Saga-Ken Medical Centre Koseikan
Division name	Department of Hepatobiliary and Pancreatology
Address	400 Nakabaru. Kase-machi, Saga-shi, Saga 840-8571, Japan
TEL	0952-24-2171
Homepage URL
Email	kawaguy222@gmail.com

Sponsor
Institute	Saga-Ken Medical Centre Koseikan
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	Canon Inc.
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2015 Year 06 Month 19 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2014 Year 09 Month 24 Day
Anticipated trial start date	2015 Year 01 Month 05 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	Retrospective study: Exploring of new imaging biomarkers for survival among the patients under sorafenib treatment since it was commercially available in 2008. Follow-up CT scans were taken every 2-3 mo for evaluation. Such biomarkers may include longest diameter, lesion volume and HU density. Prospective study: Based on the best results of retrospective study, prediction/classification ability for survival will be validated by supporting physicians' medication decision on sorafenib. Follow-up CT scans will be taken every 2-3 mo for evaluation.

Management information
Registered date	2015 Year 06 Month 17 Day
Last modified on	2017 Year 06 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000020805